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Duration of ANtibiotic therapy for CEllulitis (DANCE)


- candidate number15998
- NTR NumberNTR4360
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2014
- Secondary IDsNCT02032654 NL44512.018.13
- Public TitleDuration of ANtibiotic therapy for CEllulitis (DANCE)
- Scientific TitleDuration of Antibiotic Therapy for Cellulitis (DANCE): a Randomized Controlled Trial Comparing 6 to 12 Days of Antibiotic Therapy for Patients Hospitalized With Cellulitis
- ACRONYMDANCE
- hypothesisThere is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.
- Healt Condition(s) or Problem(s) studiedErysipelas, Cellulitis
- Inclusion criteria- Admitted to receive intravenous antibiotics for cellulitis/erysipelas
- 18 years of age or older
- Capable of giving written informed consent, able to comply with study requirements and restrictions
- Exclusion criteria- Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders.
- Concurrent use of antibiotics for other indications
- Alternative diagnosis accounting for the clinical presentation.
- All cases involving any of the following complicating factors:
-- Use of antibiotics with Gram-positive activity for more than 4 days in the past 7 days
-- Intensive care unit admission during the last 7 days
-- Severe peripheral arterial disease (Fontaine IV)
-- Severe cellulitis necessitating surgical debridement or fascial biopsy
-- Necrotizing fasciitis
-- Periorbital or perirectal involvement
-- Surgery
-- Life expectancy less than one month
-- Risk factors associated with Gram-negative pathogens as a causative agent:
--- Chronic or macerated infra-malleolar ulcers, or infra-malleolar ulcers with previous antibiotic treatment, in patients with diabetes mellitus.
--- Neutropenia
--- Cirrhosis (Child-Pugh class B or C)
--- Intravenous drug use
--- Human or animal bite
--- Skin laceration acquired in fresh or salt open water
--- Fish fin or bone injuries
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingTriple
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2013
- planned closingdate1-feb-2017
- Target number of participants396
- InterventionsPatients are included on day 1 of their hospital cellulitis episode, and judged on eligiblity for randomization on day 5-6. To qualify for randomization, patients must respond to therapy, defined as absence of fever (temp > 38.0C) and improvement in cellulitis severity score (see below). Arm 1: Short course (6 days antibiotics, 6 days placebo), experimental Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Placebo (for flucloxacillin 500mg) 500mg capsules, every 6 hours, for 6 days Arm 2: Standard course (12 days antibiotics), active comparator Flucloxacillin (1000mg iv OR, later, 500mg capsules), every 6 hours, for 6 days, followed by: Flucloxacillin 500mg capsules, every 6 hours, for 6 days
- Primary outcomeResolution of cellulitis at 14 days, defined as disappearance of warmth and tenderness at the site of infection, with substantial improvement in erythema and edema, and without recurrence by day 28, defined as the need of additional antibiotic therapy for cellulitis.
- Secondary outcome- Recurrence of cellulitis by day 90, defined as the need for additional antibiotic therapy for cellulitis

- Objective speed of recovery, measured by improvement in cellulitis severity score (a 7 item scoring system, each with a score between 0-3; items are erythema, warmth, tenderness, edema, ulceration, drainage and fluctuance). Determined at day 1, day 2-3, day 5-6, day 14, and day 28

- Quality of Life scores, using questionnaires Dutch SF-36 and EQ-5D at day 1, day 28, and day 90

- Health care resource utilisation, determined by total antibiotic use and effect on direct and indirect health-care associated costs, using modified versions of iMTA's Productivity Cost Questionnaire (iPCQ) and Medical Consumption Questionnaire (iMCQ). Measured at day 5-6, day 28 and day 90.

- Subjective speed of recovery, using visual Analog Scales (0-10) on pain and on swelling. Determined at day 1, day 2-3, day 5-6, day 14, day 28, and day 90

- Additional antibiotic usage, measuring total usage of additional antibiotics for cellulitis between the end of treatment and day 90.

- Time to relapse; time between end of treatment and the need for additional antibiotics for cellulitis



Additional analyses:
Cellulitis severity score subgroup analysis, to see if the height of the cellulitis severity score influences outcome, using a regression analysis with interaction term for severity score.

Diabetes mellitus subgroup analysis, to see if having diabetes mellitus influences outcome, using a regression analysis with interaction term for diabetes.

Per protocol analysis: like main outcome, but the following will be included: (i) patients with treatment failure, who have received at least 24 hours of study medication, and (ii) patients with treatment success, who have received at least 80% of study medication. Treatment failure is defined as the persistence or progression of signs and symptoms of the acute process after randomization, or the inability to complete the study owing to adverse events. The response is deemed indeterminate when the patients (i) received less than 80% of the study drug for reasons other than treatment failure, (ii) acquired a concomitant infection outside of the skin requiring antibiotic treatment, (iii) were lost to follow-up, or (iv) died unrelated to the primary diagnosis.

Adjustments for baseline covariates: sensitivity analysis, adjusting the primary outcome for baseline covariates
- TimepointsVisits scheduled for day 1, day 2-3, day 5-6, day 14, day 28, and day 90.
- Trial web sitehttp://www.dancetrial.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES D.R. Cranendonk
- CONTACT for SCIENTIFIC QUERIES D.R. Cranendonk
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryCellulitis is among the most common infections leading to hospitalization, yet the optimal duration of therapy remains ill defined. Pragmatically, Dutch guidelines advise 10-14 days of antibiotics, which is the current standard of care. Recently it has been shown that antibiotic treatment for pneumonia and urinary tract infections can safely and significantly be shortened. Importantly, in an outpatient setting, treatment of uncomplicated cellulitis with 5 days of antibiotics was as effective as 10 days. We hypothesize that there is no difference in outcomes when patients hospitalized with cellulitis are treated with either a short-course (6 days) or standard-course (12 days) of antibiotics.
- Main changes (audit trail)
- RECORD7-jan-2014 - 12-feb-2014


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